Contents Editor’s Letter First 2021 GaBI Journal issue highlights Original Research Biosimilars – status in July 2020 in 16 countries An assessment of trends in the Iranian pharmaceutical market following domestic production of selected medications (2007‒2017) and new considerations for health policymakers Review Article Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers…

Editor's Letter

Published on 23 February 2021

First 2021 GaBI Journal issue highlights

The articles in this first issue contain a large volume of useful information on the global development, approval, manufacturing, marketing, and uptake of biosimilars. The first Original Research by Dr Hye-Na Kang et al. from the World Health Organization (WHO) presents an extensive listing of data on the status of approved similar biotherapeutic products. While,…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1001.001

Author byline as per print journal: Marta Zuccarelli1, PharmD; Benjamin Micallef1, PharmD; Mark Cilia1, PharmD; Anthony Serracino-Inglott1,2, PharmD; John-Joseph Borg1,3, PhD Introduction/Study Objectives: The development of biosimilars is challenging due to the complexity of the active substances as well as the strict regulatory requirements to show similarity with a reference medicinal product. This review aims…

biosimilars, clinical development programmes, EMA, EPARs, regulatory, safety

DOI: 10.5639/gabij.2021.1002.009

Author byline as per print journal: Pieter J Glerum1,2, MSc; Mert Hayta1,3, PharmD, MSc; David M Burger4, PharmD, PhD; Cees Neef5, PharmD, PhD; Marcel L Bouvy3, PharmD, PhD; Marc Maliepaard1,6, PhD Background: Drug switching describes switching between drug products with the same active substance. Drug switching occurs commonly in the Netherlands and mostly between generic drug…

Brand-name drugs, drug switching, generic drugs, generics substitution, interchangeability, pharmacy practice

DOI: 10.5639/gabij.2021.1003.014

Author byline as per print journal: Mansour Somaily1, MD; Hana Alahmari1, MD; Wejdan Abbag2; Shahenda Yousif4, MD; Nawar Tayfour4, MD; Nouf Almushayt2; Saleh Alhusayni3, MD; Saeed Almajadiah4, MD Background: A biosimilar version of infliximab (CT-P13) was recently approved for use in Saudi Arabia. Clinical data support its use in the treatment of rheumatic disease, however,…

Ankylosing spondylitis, Bechet's disease, CT-P13, infliximab, rheumatoid arthritis

DOI: 10.5639/gabij.2021.1002.007

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Steven Simoens4, MSc, PhD; Amanj Kurdi1,5, BSc, PhD; Gisbert Selke6; John Yfantopoulos7, PhD; Andrew Hill8, PhD; Jolanta Gulbinovič9, MD, PhD; Antony P Martin10,11, MA, PhD1; Angela Timoney1,12, BPharm, PhD; Dzintars Gotham13, MBBS; Janet Wale14, PhD; Tomasz Bochenek15, PhD; Iva Selke Krulichova16, MSc, PhD; Eleonora Allocati17,…

cancer, cross-national, Europe, generics, health policies, pricing

DOI: 10.5639/gabij.2021.1002.008

Author byline as per print journal: Marzieh Zargaran1, PharmD, PhD Candidate; Abdol Majid Cheraghali 2,3, PharmD, PhD; Fatemeh Soleymani1,2, PharmD, MPH, PhD; Rajabali Daroudi4, BSc, MSc, PhD; Ali Akbari Sari4, MD, PhD; Professor Shekoufeh Nikfar1,2, PharmD, MPH, PhD Background: Enacting national policies which empower the local production of medications is a promising way to improve…

Domestic production, Iranian health policy, medicines consumption, pharmaceutical industry, pharmaceutical market, trend analysis

DOI: 10.5639/gabij.2021.1001.003

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Teh Kee Siang, BSc (Pharm)(Hon); Associate Professor Chan Lai Wah, BSc (Pharm)(Hon), PhD Continuous manufacturing (CM) is the integration of a series of unit operations, processing materials continually to produce the final pharmaceutical product. In recent years, CM of pharmaceuticals…

batch manufacturing, challenges, continuous manufacturing, harmonization, opportunity, regulatory

DOI: 10.5639/gabij.2021.1001.004

Contents Editor’s Letter Medical journal publication during global stress Editorial Is the local tolerance of injectable biosimilars too underestimated? Commentary A white paper: US biosimilars market on pace with Europe Original Research Physicochemical stability of the bevacizumab biosimilar, ABP 215, after preparation and storage in intravenous bags Local policies on biosimilars: are they designed to…

Editor's Letter

Published on 30 November 2020

Medical journal publication during global stress

This issue of the GaBI Journal is being published during one of the most turbulent periods in over a century. A deadly pandemic is raging, the global economy is stressed, and the negative impacts of global weather changes as well as both the number and impact of regional conflicts are all increasing rapidly. While these…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0904.023

Author byline as per print journal: Farhang Rezaei, PharmD; Nassim Anjidani, PharmD Background: The advent of follow-on biologicals in Iran and biosimilars worldwide have provided various treatment options for several severe and chronic diseases. The goal of the present study was to provide an overview of their current status in Iran. Methods: A comprehensive search of…

Author(s): Farhang Rezaei, PharmD, Nassim Anjidani, PharmD

biosimilars, Biotechnological therapeutics, follow-on biologics, Iran

DOI: 10.5639/gabij.2021.1002.010

Author byline as per print journal: Hye-Na Kang1, PhD; Robin Thorpe2, PhD; Ivana Knezevic1, PhD; Daehyun Baek3, PhD; Parichard Chirachanakul4; Hui Ming Chua5; Dina Dalili6, PhD; Freddie Foo7, MSc; Kai Gao8, PhD; Suna Habahbeh9, PhD; Hugo Hamel10, PhD; Edwin Nkansah11, PhD; Maria Savkina12, PhD; Oleh Semeniuk13; Shraddha Srivastava14; João Tavares Neto15, PhD; Meenu Wadhwa16, PhD;…

approval, biosimilar, survey, World Health Organization (WHO)

DOI: 10.5639/gabij.2021.1001.002